High Concentration Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma
NCT ID: NCT04725851
Last Updated: 2022-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
36 participants
INTERVENTIONAL
2022-07-26
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
High Concentration Oxygen Therapy for Pneumocephalus in Chronic Subdural Haematoma: A Prospective Observational Study
NCT05143216
Correcting Hypocapnia in Aneurysmal Subarachnoid Hemorrhage.
NCT07343232
Normobaric Hyperoxia for Intracerebral Hemorrhage
NCT04144868
Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy
NCT06268275
To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation
NCT01624545
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Pneumocephalus is very common after burr hole drainage for CSDH. The use of high-flow oxygen had been reported to be effective in small case series, showing effectiveness in clinical and radiological outcomes. However, no large, prospective, controlled trial has been conducted to establish the efficacy of oxygen therapy on functional outcomes for patients with pneumocephalus after burr hole drainage in CSDH.
Bilateral CSDH has a different prognosis and is associated with a poorer outcome.
In addition to treating pneumocephalus, the use of perioperative oxygen has been suggested to minimize tissue hypoxemia and infection. In a study published in the New England Journal of Medicine, the use of perioperative supplementary oxygen was shown to reduce surgical site infection.
Hyperoxia with oxygen therapy has shown to be safe with minimal changes to the cerebral blood flow (CBF) from functional magnetic resonance imaging (fMRI).
Research Questions
1. Does post-operative high-flow oxygen improve pneumocephalus in terms of volume reduction in CSDH patients after burr-hole drainage?
2. Does post-operative high-flow oxygen reduce the recurrence rate of CSDH (radiologically) if pneumocephalus volume is reduced after oxygen therapy?
3. Does post-operative high-flow oxygen reduce the recurrence rate of CSDH (clinically), as defined by symptomatic recurrence requiring reoperation, if pneumocephalus volume is reduced after oxygen therapy?
4. Does post-operative high-flow oxygen improve CSDH patients' functional outcome in terms of modified Rankin Scale (mRS) at 3 months and 6 months?
Hypothesis Oxygen therapy for CSDH patients with post-operative pneumocephalus will experience significant resorption of intracranial air within 24 hours. There is a reduction in recurrence rate in terms of the re-operation rates. There is an improvement in functional outcome in terms of mRS.
Aim of the Study To evaluate changes in pneumocephalus volume and functional outcome after oxygen therapy in post-operative CSDH patients treated by burr hole drainage, as compared to the standard care by breathing in room air or low concentration oxygen during the post-operative period.
Study Design Prospective randomized 1:1 parallel-arm study
Methods and Randomization Patients will be recruited when they are considered fit for oxygen therapy as determined by the treating clinician. The timing of burr hole evacuation may vary according to the availability of the emergency operative time slot. The index intervention is postoperative oxygen therapy: 100% normobaric oxygen through a nonrebreather mask (NRM) at 12-15 Litre/minute consecutively for 24 hours. Removal of the nonrebreather mask is allowed during meals or other activities such as physiotherapy. The duration of mask removal would be documented. Compliance with NRM is considered to be good if the mask is kept \> 90% of the time during the 24 hours treatment period. The reference intervention is standard post-operative care: the patient would be breathing in normobaric room air. For the reference arm, if the patient has desaturation (i.e. SaO2 \< 93%), supplemental O2 therapy can be given to keep SaO2 \> 93%. Arterial blood gas would be obtained by the clinicians when deemed necessary. If there is a significant deviation from the study protocol occurs, the patients will be analyzed according to their originally assigned groups (intention-to-treat principle).
Non-rebreather masks, when they are tightly applied, are associated with a lower aerosol dispersion distance (as compared to non-invasive positive pressure ventilation or venturi masks).
Interim data analysis would be performed and the study would be terminated if a significant difference in the primary outcome is observed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High concentration Oxygen Therapy
12-15 Litre/min O2 delivery via Non-Rebreather Mask (NRM) consecutively for 24 hours.
High concentration Oxygen therapy
FiO2 \>80% Oxygen (Delivered with 12-15L/min Non-rebreather Mask)
Room air or low concentration oxygen
Room air or low concentration oxygen (0-2 Litre/min O2 ) consecutively for 24 hours.
Control: Room Air or Low concentration Oxygen
FiO2 \<30% Oxygen (Delivered with 0-2L/min Nasal Cannula)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
High concentration Oxygen therapy
FiO2 \>80% Oxygen (Delivered with 12-15L/min Non-rebreather Mask)
Control: Room Air or Low concentration Oxygen
FiO2 \<30% Oxygen (Delivered with 0-2L/min Nasal Cannula)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Presence of chronic subdural haematoma (CSDH) as diagnosed radiologically either by computed tomography (CT) brain scan or magnetic resonance imaging (MRI).
3. Treatment of CSDH by burr-hole evacuation.
4. Presence of post-operative pneumocephalus, as evidenced from post-operative CT Brain or MRI brain
5. Negative test to SARS-nCoV-2, as evidenced by either deep throat saliva rapid test, deep throat saliva PCR test, nasopharyngeal swab real-time PCR test, or nasopharyngeal swab rapid test within seven days.
Exclusion Criteria
2. Any pre-existing illness that renders the patient moderately or severely disabled before diagnosis with CSDH, such as a history of central nervous system infection.
3. CSDH arising from secondary causes, such as intracranial hypotension, thrombocytopenia, etc.
4. Any evidence or suspicion that there is communication between the pneumocephalus with the air cells (e.g. such as mastoid air cells) or air sinuses (e.g. frontal sinus).
5. Patients that need an additional procedure e.g. epidural blood patch, etc.
6. Complications arising from the burr-hole operation or subdural drain insertion such as hemorrhage or surgical site infection requiring surgical intervention or deemed to affect the patient's long-term functional outcome.
7. Patients already on long-term steroid for pre-existing medical conditions.
8. Participation in other clinical trials within four weeks upon recruitment.
9. Pregnancy or on breastfeeding.
10. Any other reasons that the researchers consider the patients to be unsuitable.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chinese University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. David Yuen Chung CHAN
Clinical Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David YC Chan, MBBS, FRCS
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Wai S Poon, MBChB, FRCS
Role: STUDY_CHAIR
Chinese University of Hong Kong
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Division of Neurosurgery, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Gore PA, Maan H, Chang S, Pitt AM, Spetzler RF, Nakaji P. Normobaric oxygen therapy strategies in the treatment of postcraniotomy pneumocephalus. J Neurosurg. 2008 May;108(5):926-9. doi: 10.3171/JNS/2008/108/5/0926.
Dexter F, Reasoner DK. Theoretical assessment of normobaric oxygen therapy to treat pneumocephalus. Anesthesiology. 1996 Feb;84(2):442-7. doi: 10.1097/00000542-199602000-00024.
Greif R, Akca O, Horn EP, Kurz A, Sessler DI; Outcomes Research Group. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. N Engl J Med. 2000 Jan 20;342(3):161-7. doi: 10.1056/NEJM200001203420303.
Xu F, Liu P, Pascual JM, Xiao G, Lu H. Effect of hypoxia and hyperoxia on cerebral blood flow, blood oxygenation, and oxidative metabolism. J Cereb Blood Flow Metab. 2012 Oct;32(10):1909-18. doi: 10.1038/jcbfm.2012.93. Epub 2012 Jun 27.
Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.
Miranda LB, Braxton E, Hobbs J, Quigley MR. Chronic subdural hematoma in the elderly: not a benign disease. J Neurosurg. 2011 Jan;114(1):72-6. doi: 10.3171/2010.8.JNS10298. Epub 2010 Sep 24.
Chan DYC, Poon WS, Chan DTM, Mak WK, Wong GKC. Chronic subdural haematoma during the COVID-19 lockdown period: late presentation with a longer interval from the initial head injury to the final presentation and diagnosis. Chin Neurosurg J. 2021 Jan 8;7(1):4. doi: 10.1186/s41016-020-00229-7.
Chan DY, Woo PY, Mak CH, Chu AC, Li CC, Ko NM, Ng SC, Sun TF, Poon WS. Use of subdural drain for chronic subdural haematoma? A 4-year multi-centre observational study of 302 cases. J Clin Neurosci. 2017 Feb;36:27-30. doi: 10.1016/j.jocn.2016.10.039. Epub 2016 Nov 30.
Chan DY, Chan DT, Sun TF, Ng SC, Wong GK, Poon WS. The use of atorvastatin for chronic subdural haematoma: a retrospective cohort comparison study. Br J Neurosurg. 2017 Feb;31(1):72-77. doi: 10.1080/02688697.2016.1208806. Epub 2016 Nov 23.
Chan DYC, Sun TFD, Poon WS. Steroid for chronic subdural hematoma? A prospective phase IIB pilot randomized controlled trial on the use of dexamethasone with surgical drainage for the reduction of recurrence with reoperation. Chinese Neurosurgical Journal. 2015; 1(1):2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NTEC-2021-0021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.